Drug Ruling Puts Devices in Spotlight

An injured consumer can sue a drug maker — but not a medical device maker?

That seemed to be the contradictory result of a decision Wednesday by the Supreme Court, ruling that federal law does not protect drug companies from product liability suits in state courts.

In contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices.

The discrepancy reflects the different legal issues in the two cases. But the fallout from Wednesday’s decision, legal experts said, could be considerable for drug and device makers alike.

Drug makers, for their part, may now face a flood of new lawsuits. They may also feel compelled to settle current litigation that would have been dismissed if the Supreme Court decision had gone their way.

Meanwhile, influential members of Congress plan to introduce a bill soon that would supersede last year’s Supreme Court device ruling, their aides say. If that legislation became law, injured people or their survivors would have the same right to sue device makers that the Supreme Court on Wednesday gave to people claiming injury or death from unsafe drugs.

“I think this is going to force Congress to revisit the issue of why medical devices should be insulated from lawsuits,” said David C. Vladeck, a professor at Georgetown University Law Center who supports a law to counteract last year’s device decision.

In the case decided Wednesday, involving a Wyeth drug, the Supreme Court ruled that a patient injured by a drug can sue the maker, even though the Food and Drug Administration oversees warnings on drug labels about possible side effects. Wyeth had argued that federal oversight of drug labels precluded state courts from hearing drug injury cases.

Drug industry supporters warned that the decision would make companies more reluctant to produce beneficial drugs that come with higher risks. But plaintiffs’ lawyers and patient advocacy groups hailed the ruling.

“The decision means for consumers that they can now sue drug companies when drug companies do not label their products properly,” said Arnold Levin, a Philadelphia plaintiffs’ lawyer who in the 1990s was a lead counsel in the successful class action suit over the diet drug combination fen-phen. “I think the entire drug industry thought the Supreme Court decision would go their way.”

Peter J. Pitts, a former associate commissioner of the F.D.A. who is now a public relations executive representing drug makers, predicted a flood of consumer lawsuits. The court’s decision frees consumers, to their detriment, he said, from the responsibility of weighing the benefits and risks of a drug.

“It means the F.D.A. label does not provide any cover for the drug industry,” Mr. Pitts said. “Tort lawyers will see this as a pot of gold at the end of the rainbow.”

Drug companies may now be more likely to settle some lawsuits they had hoped would be dismissed.

Christopher A. Seeger, a Manhattan lawyer, whose law firm, Seeger Weiss, was a party to the plaintiff’s suit in the Wyeth case, said his firm was also suing the pharmaceutical company Roche on behalf on 500 patients who took the acne drug Accutane and then experienced severe colon problems.

So far, Mr. Seeger has won seven Accutane cases, he said. But, even though such plaintiff victories often prompt a drug company to enter settlement talks, Roche has not, Mr. Seeger said.

“It seems to me that they were waiting around for Wyeth because maybe they would not have to face these cases because they would be dismissed,” said Mr. Seeger, who was the lead counsel on class-action suits over the pain drug Vioxx, by Merck, and the schizophrenia drug Zyprexa, made by Eli Lilly.

A Roche spokesman declined to comment on the Wyeth decision or its implications.

Others said that the decision might spur manufacturers to revise labels on drugs to reflect new information about possible side effects.

“If I’m a drug company, what I need to do is take more responsibility by updating labels on a more active basis to protect myself,” said Seamus Fernandez, an analyst with Leerink Swann, a health care investment bank.

But Mr. Pitts, the public relations executive, argued that such changes would complicate matters for patients and be a burden to manufacturers, because drug makers need to seek F.D.A. approval for every label change.

“When you begin to lawyer up the label, it is deleterious to public health,” Mr. Pitts said. “Labels are already hard enough to understand.”

Drug stocks, at least, showed few signs of stress on Wednesday, when the stock market had a broad rally. Wyeth stock rose 1.1 percent, while some other pharmaceutical shares were up more sharply, like Pfizer, which ended the day with a 5.3 percent gain.

Any impact of the Wyeth decision for device companies would depend on whether Congress does respond by overriding the device decision by the Supreme Court last year. That ruling said the 1976 law giving the F.D.A. authority over medical devices had also provided a legal shield to devices that undergo the agency’s highest level of review.

A former top F.D.A. lawyer, Peter Barton Hutt, who helped draft the 1976 law, said Wednesday that the law was intended to prevent state judges and juries from second-guessing agency decisions. The Supreme Court, by an 8-1 vote last year, agreed.

But Mr. Hutt, who now is a lawyer in Washington, said that Wednesday’s decision, which rejected Wyeth’s argument that the F.D.A. wields similar authority over drugs, might have energized members of Congress who were already eager to nullify last year’s device ruling.

“That legislation could now proceed,” said Mr. Hutt, who was not involved in either of the Supreme Court cases.

Such legislation was first introduced last year by several Democratic lawmakers, including Senator Edward M. Kennedy of Massachusetts and Representative Frank Pallone Jr., a New Jersey Democrat who is chairman of the health subcommittee of the House Energy and Commerce Committee. Their aides said Wednesday that the bill, the Medical Device Safety Act, would be reintroduced soon, although they declined to specify a timetable.

Supporters of the legislation, which is backed by plaintiffs’ lawyers, say it is necessary because the F.D.A. has repeatedly approved faulty high-risk devices for sale.

The plaintiff lawyer, Mr. Seeger, said Wednesday’s ruling had implications for both drugs and devices.

“There are 100 people at the F.D.A. in charge of monitoring 10,000 drugs and medical devices — it’s an impossible task,” Mr. Seeger said. “At the end of the day, pharmaceutical and device companies have to be responsible for the safety of those drugs and devices and, if there are risks, warn about them.”

Source: http://www.nytimes.com/2009/03/05/business/05device.html?_r=1&scp=1&sq=Drug%20Ruling%20Puts%20Devices%20in%20Spotlight&st=cse, Published March 4, 2009

About IPPF

The International Pemphigus & Pemphigoid Foundation’s most important objectives are to provide patients and doctors worldwide with information about pemphigus and pemphigoid, and to provide patients and their caregivers much needed comfort and support so they can continue to live active, productive lives.Read more »